August 5, 2005

Moonlighting at NIH

WASHINGTON - Ethics officials at the National Institutes of Health often approved senior scientists' requests to moonlight for drug companies and other outside organizations without gathering adequate documentation to help judge whether the arrangements posed conflicts of interest, federal inspectors have found.

In 81 percent of the recent outside arrangements reviewed by the inspector general of the U.S. Department of Health and Human Services, ethics officials were found to have approved the deals on the basis of "limited" information. This and other findings are included in a report by the inspector general that is to be made public today.

"In no instance was the documentation we reviewed adequate for us to make a definitive determination regarding whether an activity was appropriate," the report said. "Inadequate documentation for outside activities can, intentionally or unintentionally, hide potential violations."

The report found that information submitted by the scientists to NIH ethics officials "included insufficient detail regarding the nature of the outside activities, the nature of employees' official job duties, the differences between the outside activities and their official job duties, the outside organizations, and any NIH funding or partnerships with the outside organizations."

The advance descriptions of the outside positions to be entered into by NIH scientists "were too general to demonstrate that employees' official duties would not overlap," the report said.

The inspector general's reviewers "could not determine the appropriateness of eight activities, and they determined that two of the activities appeared to violate regulations."

The report also said, "However, it is quite possible that, due to the approach taken in this review, we have underestimated the number of activities that should not have been approved."

A copy of the 72-page report was obtained yesterday by the Los Angeles Times.

The review is another condemnation of the NIH's recent policies governing outside work by agency scientists. In July 2004, the chief of the Office of Government Ethics concluded that the NIH was beset with a "permissive culture" toward conflicts of interest. The lax policies were largely the result of an agency-wide lifting of controls in late 1995 by the then-director of the NIH, Dr. Harold E. Varmus.

Varmus' successor, Dr. Elias A. Zerhouni, announced sweeping restrictions this past February, citing reports by the Times in 2003 and 2004 that brought to light the payments by pharmaceutical and biotechnology companies of millions of dollars in consulting fees and stock to NIH scientists.

Zerhouni - prodded by the Department of Health and Human Services, the Office of Government Ethics and congressional leaders from both parties - agreed to prohibit NIH employees from accepting any further payments from pharmaceutical or biotechnology companies.

A group of NIH scientists is resisting the tougher ethics rules, which include a provision that would force employees to divest their stock in any biomedical company. They have hired a law and lobbying firm, and have called for Zerhouni to relax the ban on consulting for drug companies and to rescind the stock-divestiture provision, which has yet to be implemented.

Zerhouni has said that he is weighing the criticisms and would consider easing the restrictions if he concluded that they were inhibiting the NIH's ability to retain or recruit qualified scientists.

In a written reply to the inspector general, Zerhouni referred to the "corrective actions" that have been taken recently. He said that, generally, he agreed with the inspector general's findings, conclusions and recommendations.